UMIN-CTR Clinical Trial

Basic information
Public title	Accuracy Assessment of Exhaled Propofol Concentration Monitoring in Patients under General Anesthesia
Acronym	Assessment of Exhaled Propofol Monitor
Scientific Title	Accuracy Assessment of Exhaled Propofol Concentration Monitoring in Patients under General Anesthesia
Scientific Title:Acronym	Assessment of Exhaled Propofol Monitor
Region	Japan

Condition
Condition	Patient Undergoing Elective Surgery under General Anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To Assess a Propfol Monitor
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ratio of exhaled propofol cocentration versus plasma propofol concentration or an index simialr to the ratio during the general anesthesia
Key secondary outcomes	1. Ratio of measured propofol cocentration versus predicted plasma propofol concentration or an index simialr to the ratio during the general anesthesia 2. pharmacokinetic model to predict plasmaconcentration using exhaled propofol concentration

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Propofol will be administered using target-controlled infusion. The target concentration is controlled between 3 to 6 mcg/ml during the induction of anesthesia, and 2 to 5 mcg/ml during maintenance of anesthesia. Hydroxyethil starch 6% 130/0.4/9 of 400 to 800 ml will be infused during anesthesia. If necessary, both propofol and hydroxyethil starch will be administered beyond the limits.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient undergoing elective surgery under general anesthesia (20 patients aged 20 to 64, and 20 patients aged 65 or older)
Key exclusion criteria	(1) Contraindication to propofol or hydroxyethil starch administration (2) Obstructive and/or restrictive ventilatory impairment (3) American Society of Anesthesiologists physical status 4 or larger
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Masui
Organization	Showa University School of Medicine
Division name	Department of Anesthesiology
Zip code	142-8666
Address	Hatanodai 1-5-8, Sinagawa, Tokyo, Japan
TEL	03-3784-8575
Email	kenichi@masuinet.com

Public contact
Name of contact person	1st name Kenichi Middle name Last name Masui
Organization	Showa University School of Medicine
Division name	Department of Anesthesiology
Zip code	142-8666
Address	Hatanodai 1-5-8, Sinagawa, Tokyo, Japan
TEL	03-3784-8575
Homepage URL
Email	kenichi@masuinet.com

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Showa University
Address	Hatanodai 1-5-8, Sinagawa, Tokyo, Japan
Tel	03-3784-8000
Email	m-rinri@ofc.showa-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2019 Year 04 Month 01 Day
Date of IRB	2018 Year 03 Month 28 Day
Anticipated trial start date	2019 Year 04 Month 08 Day
Last follow-up date	2019 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 07 Day
Last modified on	2020 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041516